Human Subjects Research Project Manager - The Seattle Epidemiologic Research and Information Center (ERIC)

LOCATION: Seattle, WA

Part-time position, 40 hours per week

CLOSING DATE: open until filled

OPPORTUNITY TYPE: Job

JOB #: 18993

POSTED: September 21, 2022

Description:

Human Subjects Research Project Manager

Are you interested in helping to improve the health and healthcare of our Veterans and our nation through meaningful work in an innovative and collaborative environment? The Seattle Epidemiologic Research and Information Center (ERIC) within the VA Cooperative Studies Program (CSP) is recruiting a full-time Project Manager to work with an experienced and growing group of researchers committed to high-quality epidemiologic investigations. The Seattle ERIC is located at the VA Puget Sound Health Care System (VAPSHCS) and this position is based in Seattle, WA.

The Project Manager will:  

  1. Provide leadership, continued development, and management of the research quality management initiative and regulatory program for the Center, including being a member of the Program-wide Epidemiology Quality Team.
  2. Emphasize the importance of quality, as well as the involvement and ownership of all staff in the process, in all aspects of participant safety, privacy, and confidentiality; scientific output as it specifically relates to data quality, and general efficiency of research operations at the Center.
  3. Work closely with the Associate Center Director-Research Operations (ACD-RO) to ensure the success and regulatory compliance of several research data repositories and observational epidemiologic studies addressing COVID-19, environmental and occupational exposures, and genetics.
  4. May also provide regulatory, operational, and quality support to research and the Program’s transition to VA’s new electronic health record (EHR).

Key Duties:

  • Participate in the wider development of the research quality management system (QMS) to be used by CSP Epidemiology Centers by helping to review processes and identify gaps; by creating and updating quality documentation; and by supporting the development of a content and document management system.
  • Facilitate and participate in fact-finding interviews between the CSP Epidemiology Center Quality Team and data management and research process owners. 
  • Work with Center leadership to ensure resulting CSP Epidemiology Center QMS is implemented and integrated into all aspects of our Center’s work.
  • Create, implement, and maintain QMS training plans; ensure staff members know their roles and responsibilities.
  • Interface with all levels of staff to identify and implement continuous improvement opportunities, best practices, and preventative actions.
  • Proactively stay up-to-date on regulations, policies, interpretations, and best practices related to human subjects research, privacy, data and information security, and data sharing from multiple levels (Federal, VA, VA research, CSP, local VA facility).  
  • Develop and maintain quality assurance processes, procedures, and documentation for achieving adherence to regulations throughout study and repository lifecycles.
  • Manage Center regulatory processes and assist with responses to complex regulatory inquiries.
  • Educate and train staff in the fundamentals of ethical research.
  • Supervise and manage a small Center quality team.
  • Establish and foster relationships and collaborations within CSP and with other stakeholders.
  • Develop mitigation strategies and opportunities for improvement before, during, and after the transition to the new EHR as it relates to EHR data used by research data repositories and observational epidemiologic studies.
  • Serve as an interim project manager on newly assigned studies and initiatives.

 

 

 

 

 

Qualifications:  

Required:

  • US citizenship
  • Minimum of a bachelors-level degree in a scientific field
  • At least 3 years of research management experience
  • Record of leadership and team building in a research environment
  • Self-starter with demonstrated ability to effectively lead and manage complex research projects
  • Excellent communication and interpersonal skills with the ability to collaborate with a diverse group of people with a wide range of professional backgrounds and expertise
  • Ability to adapt to evolving and competing priorities and timelines
  • Adept in troubleshooting and problem-solving 
  • In-depth knowledge of the HIPAA Privacy Rule, Common Rule, and other human subjects and data/information security protections laws and regulations, including best practices
  • Ability to clearly communicate complex research regulations and procedures
  • Familiarity with data management software/systems (e.g., MS Access, REDCap, VA Informatics and Computing Infrastructure, SQL)
  • Experience working with research documentation to include informed consent forms, HIPAA authorization forms, study protocols, and operations manuals

Preferred:

  • Masters-level degree in a scientific or related-field
  • Experience implementing or managing quality management systems
  • Extensive experience managing multiple large-scale research studies, including oversight of instrumentation development, data collection, and general operations
  • Knowledge of VA research operations
  • Experience with EHR data

Salary:

Depending on the candidate’s experience, the target salary will be in the GS-11 to GS-13 range according to the Office of Personnel Management General Schedule table at opm.gov.

How to Apply:

How to apply:

Send a cover letter and resume to SeattleCSPEC@va.gov. Applications will be accepted until the position is filled; however, materials received by 10/07/2022 will be considered first.

 

Diversity enriches research and promotes the best healthcare. We are committed to building and sustaining an equitable and inclusive environment for our Center. We encourage individuals whose backgrounds or interests align with this commitment, as well as individuals from all backgrounds that are underrepresented in research, to apply.

 

About CSP and Seattle ERIC:

The VA Cooperative Studies Program (CSP) is a nationally renowned division of the VA’s Office of Research and Development (ORD) and responsible for the planning and conducting of large, multisite clinical trials and epidemiological studies within VA.

 

The Seattle ERIC designs and conducts large-scale observational epidemiologic studies, maintains high-quality data resources to support VA research, and is one of several Epidemiology Centers within CSP.  

 

For more information about the Seattle ERIC, please see https://www.seattle.eric.research.va.gov/Employment/Main.asp.

 

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